REDACTED - 8/2003 First Quarter 2000 Summary of ...1 SUMMARY OF INCIDENTS FOR FIRST QUARTER 2000...

i

REDACTED - 8/2003

First Quarter 2000 Summary of Incidents, Complaints, Enforcement Actions

Prepared by

Bradley Caskey, Helen Watkins, James OgdenIncident Investigation

Cathy McGuire - Escalated Enforcement

Texas Department of HealthBureau of Radiation Control

Division of Compliance & Inspection

Telephone: 512/834-6688

i NOTE: Items within these summaries have been redacted(blackened out) due to confidential medical information under the

Medical Practice Act and The Texas Public Information Act.

“Any complaints and or incidents involving hospitals on or after August 30, 1999 are notreleasable under the Texas Public Information Act & The Health and Safety CodeChapter 241.051 (d). The text of these summaries will not appear in this report.”

Copies of this report are available on the internet athttp://www.tdh.state.tx.us/ech/rad/pages/brc.htm

http://www.state.tx.us/radiation

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TABLE OF CONTENTS

Summary of Incidents for First Quarter 2000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Summary of Complaints for First Quarter 2000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Incidents Closed since Fourth Quarter 1999 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Complaints Closed since Fourth Quarter 1999 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Appendix A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Summary of Hospital OverexposuresReported during First Quarter 2000

Appendix B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Summary of Radiography OverexposuresReported during First Quarter 2000

Appendix C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Enforcement Actions for First Quarter 2000

1

SUMMARY OF INCIDENTS FOR FIRST QUARTER 2000

I-7558 - Stolen Nuclear Gauge - Terra-Mar, Inc. - Fort Worth, Texas

On January 3, 2000, the Licensee notified the Agency of a stolen nuclear density gauge. A pickuptruck, containing the gauge, was not returned from a work site on December 30, 1999. Thedriver/operator was also missing. The vehicle, with the gauge and other tools, was reported stolento the Ft. Worth Police Department. On January 4, 2000, the truck, with the gauge inside, wasfound parked outside the Licensee’s Dallas office. The gauge was leak tested with no leakagedetected. The gauge was returned to service. The Licensee terminated the driver/operator’semployment..

File Closed.

I-7559 - Misadministration - University of Texas Health Science Center San Antonio (UTHSCSA)- San Antonio, Texas

On January 6, 2000, the Registrant notified the Agency of a therapy misadministration thatoccurred as the result of a dosimetry error at the Cancer Therapy and Research Center (CTRC).Agency investigators determined that the dosimetry was miscalculated because the default isotopeiodine-125 was selected by the Radiation Oncology Computer System (ROCS) when iridium-192was not manually selected. The resulting calculated implant time of 64 hours resulted in atreatment dose greater than 10% of the prescribed dose. The late discovery of themisadministration was due to the failure of CTRC to follow internal procedures and performrequired comparative calculations within 3 days of delivery of one-half of the prescribed dose.After discovery of the misadministration both the referring physician and the patient were notifiedof the error. The dose delivered was within the upper limits for this treatment. The patient didnot suffer ill effects from the treatment delivered. Follow-up examinations will be performed ona bi-weekly basis alternating between UTHSCSA and CTRC. The CTRC has made the followingchanges to prevent recurrence of a similar event: 1) The ROCS at both facilities administered byCTRC have been changed to default to a dummy source, requiring the entry of the proper isotopebefore calculations can be performed; 2) the dosimetrist will be required to indicate in large printon the isodose representation the radionuclide selected for the procedure, prior to signature by theprescribing physician; 3) a second manual calculation will be performed by a staff physicist beforeone-half of the dose is delivered; and 4) the treatment plan will be hand carried by the dosimetristto the physicist designated to perform the manual calculations. If the designated individual isabsent, a back-up physicist will perform the calculations. If that individual should also be absentthe treatment plan will be delivered to the Director of Medical Physics who will ensure a reviewis performed.

File Closed.

2

I-7560 - Radioactive Material Found - Structural Metals, Incorporated - Seguin, Texas

On December 28, 1999, steel mill notified the Agency that radioactive material had been detectedin a load of scrap metal. An industrial smoke detector was segregated from the scrap. A Licenseetook possession of the source and identified it as 1.6 microcuries of radium-226. There were noserial numbers on the device that would allow it to be traced back to the owner. The company thatoriginally manufactured the device is no longer in business. The scrap metal company arrangedfor disposal of the device.

File Closed.

I-7561 - Radioactive Material Stolen - Petra Technologies Incorporated - Houston, Texas

On January 10, 2000, the Licensee notified the Agency of the theft of a nuclear moisture densitygauge during the hours of darkness on January 9-10, 2000. The gauge had been stored in the frontseat of the operator’s truck, under a blanket, while parked at his apartment complex. The vehiclewas broken into and the unsecured gauge, along with other items, was stolen. The Licensee wascited for failure to secure the radioactive material from unauthorized removal.

File Inactive.

I-7562 - Equipment Malfunction - Union Carbide - Port Lavaca, Texas

On December 9, 1999, the Licensee notified the Agency of an equipment malfunction thatoccurred on December 5, 1999. A source cable stop on a gauge fell off its mounting position,pulling a source below its normal operating position. The lower position created a slightly higherthan normal radiation field in the area around the source. Exposures to workers were minimal.The Licensee’s investigation revealed the lock nut that holds the stop in place was missing. A locknut was added to the unit. To prevent a recurrence, a check of the lock nut was added to theroutine inspection.

File Closed.

3

I-7563 -* Health and Safety Code-Chapter 241.051(d)

File Closed.

I-7564 - Radioactive Material Found - Structural Metals, Incorporated - Seguin, Texas

On January 11, 2000, the scrap metal company notified the Agency that a 1.7 microcurie radium-226 source was segregated from a load of scrap on September 7, 1999. There were no serialnumbers or other identifying markings that would allow the source to be identified or traced to anowner. An authorized Licensee analyzed and took possession of the source for disposal.

File Closed.

I-7565 - * Health and Safety Code-Chapter 241.051(d)

File Closed.


File Closed.

I-7567 - Overexposure - Radiographic Specialists Incorporated - Houston, Texas

On January 24, 2000, the Licensee notified the Agency of a 5,985 millirem exposure to aradiographer during the 1999 monitoring period. An Agency investigation confirmed theexposure. The investigation could not determine any instances of reported off-scale pocketdosimeters, separation of the film badge from the body during radiography, unintentional ordeliberate exposure of the film badge, or any instance when the radiographer’s alarming rate meteractually alarmed during radiography operations. Film badge records of two co-workers who hadworked with the radiographer during all jobs conducted during the period had badge readings ofonly 125 millirem and 195 millirem respectively. The investigation could not determine the causeof the exposure. The Licensee was cited for allowing an employee to exceed the annual wholebody occupational dose limit.

File Closed.

I-7568 - Overexposure - Technical Welding Labs - Pasadena, Texas

On January 21, 2000, the Licensee notified the Agency of a 5,071 millirem whole body exposureto a radiographer during the 1999 monitoring period. An Agency investigation determined the

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exposure resulted from long work hours during the last month of the year. The radiographeraveraged 100 hours per week at various temporary job sites. During some exposures, theradiographer was unable to maintain adequate distance from the source. After learning of theexcessive dose, the Licensee temporarily assigned the radiographer to work not involvingradioactive material. To prevent a recurrence, the Licensee began weekly audits of jobperformance, increased safety meetings to twice weekly and stressed keeping exposures as low aspossible. The Licensee was cited for the violation.

File Closed.


File Closed.


File Closed.

5


File Closed.


File Closed.


File Closed.

I-7574 - Overexposure - GCT Inspection - South Houston, Texas

On February 14, 2000, the Licensee notified the Agency of a 5,205 millirem whole body exposureto a radiographer during the 1999 monitoring period. An Agency investigation determined theradiographer received 3,430 millirems of the total exposure during the September 15, 1999,through October 14, 1999, monitoring period. The radiographer could not recall any unusualactivity that led to the exposure. He did not work excessive hours, his pocket dosimeter did notgo off-scale, and his alarming ratemeter did not alarm. The Licensee was cited for the exposureand for failure to return the monitoring device to the processor within fourteen days afterexchange.

File Closed.


File Closed.


File Closed.

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File Closed.


File Closed.

I-7579 - Stolen Portable Nuclear Gauge - HTS, Inc. - Houston, Texas

On February 8, 2000, the Licensee notified the Agency of the theft of a portable nuclear gauge.The chain securing the gauge in the company vehicle had been cut and the transport box and thegauge were stolen. The gauge was recovered on February 12, 2000, approximately five blocksfrom the location where the operator had stopped for breakfast enroute to the job site.

File Closed.

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File Closed.


File Closed.


File Closed.

8

I-7583 - Stolen Nuclear Gauge - Fugro-McClelland, Inc. - Fort Worth, Texas

On March 24, 2000, the Licensee notified the Agency that a moisture density gauge was stolenfrom a work site when the gauge was left unattended by the operator. The gauge was recoveredthree days later, when the finder brought the gauge to a rental company for an assessment of thevalue and was advised to turn the damaged gauge into the City of Arlington. The gauge wasdetermined to have a broken source rod. The Nuclear Regulatory Commission was notified of thetheft and recovery of the nuclear gauge. An Agency investigation determined that all sources werestill in place in the gauge and no one was exposed to the gauge. The gauge was returned to themanufacturer for repair. The Licensee was cited for failure to secure radioactive material fromunauthorized removal.

File Closed.


File Closed.


File Closed.

9

I-7586 - Equipment Damaged - Richmond Foundry - Richmond, Texas

On March 2, 2000, the Licensee notified the Agency that a 7.8 curie cobalt 60 radiography sourcecould not be returned to the shielded position. During the performance of radiography inside astationary bay, a steel block fell on the guide tube and crimped it, preventing the source’s returnto the shielded position. The source became lodged in a six foot extension tube. The radiographersecured the area, locked the bay, and notified the radiation safety officer (RSO). The RSOcontacted an authorized Licensee to retrieve the source. Using remote handling tools and anoverhead crane, the source was retrieved without further incident. The individual who retrievedthe source received an 83 millirem whole body exposure and a 130 millirem right hand exposure.To prevent a recurrence, the steel block used for film identification was repositioned for greaterstability.

File Closed.

I-7587 - Radioactive Material Lost - ALUMAX Mill Products, Inc. - Texarkana, Texas

On April 7, 2000, the Licensee notified the Agency that the facility was in possession of 250microcurie polonium-210 static eliminators not authorized by their General LicenseAknowledgement. The radiation safety officer (RSO) was able to locate only 8 of 19 unauthorizedsources that had been acquired by the facility. The RSO took actions to determine the origin ofthe unauthorized sources, collected all unauthorized sources found at the facility, attempted tolocate any remaining unauthorized sources, stopped use of these unauthorized sources, and disposeof all unauthorized sources found. All sources were leak tested and disposed of on April 26,2000. The missing anti-static sources are believed to have been inadvertently disposed.

File Closed.

I-7588 - Badge Overexposure - M.D. Anderson Cancer Center - Houston, Texas

On March 31, 2000, the Registrant notified the Agency of a 11,430 millirem exposure to aphysician during the February 2000 monitoring period. The Registrant believes the personnelmonitoring badge was worn with the film improperly loaded. The badge processor noted therewere no filter patterns on the film indicating the film was exposed outside the holder. An Agencyinvestigation concurred with the Registrant’s findings. A deletion was granted and an assessmentof 250 millirems, based on a recalculation for low energy and the use of a protective apron whileusing fluoroscopy equipment, was accepted.

File Closed.

10

I-7589 - Off Scale Dosimeters - Cooperheat- MQS, Inc. - Houston, Texas

On March 27, 2000, the Licensee notified the Agency that two radiographer’s pocket dosimetershad gone off scale during radiography operations. The radiographers had been working with a63 curie iridium-192 camera. Their personnel monitoring badges were submitted for analysis andindicated 300 millirem and 480 millirem whole body exposures. The Licensee’s investigationdetermined that the source had not been returned to the fully shielded and locked position. Theradiographers indicated that during the incident they did use an alarming rate meter. The Licenseewas cited for the violations.

File Closed.

11

SUMMARY OF COMPLAINTS FOR FIRST QUARTER 2000

C-1447 - Regulations Violations - Industrial Nuclear Company, Incorporated - Houston, Texas

On January 21, 2000, the Agency received an anonymous complaint alleging that the Licensee didnot have a radiation safety officer and did not document the receipt of iridium-192 sources. AnAgency investigation substantiated the allegations. The Licensee was cited for these and otherviolations discovered during the investigation.

File Closed.

C-1448 - Regulation Violations - Paramount Event Services - San Antonio, Texas

On January 5, 2000, the Agency received an anonymous complaint alleging that a Registrantperformed laser light shows not in compliance with Agency regulations. Allegedly, laserinterlocks were broken; safety systems were bypassed; and the laser light was scanned too lowduring the show. The Agency monitored the set up of the lasers and the light show. No violationswere noted.

File Closed.

C-1449 - Regulations Violations - Karnes County Corrections Facility - Karnes City, Texas

On January 6, 2000, the Agency received an anonymous complaint alleging that there was anunregistered dental x-ray facility in operation at the Karnes County Corrections Facility managedby the Wackenhut Corrections Corporation. A records review did not indicate a registration noran application from the facility. An Agency investigation determined a dental x-ray machine hadbeen in operation for over 3 years. The facility submitted an application December 23, 1999, thatwas received by the Agency January 3, 2000. In addition to not being registered, the facility didnot have a posted technique chart, and had not performed an equipment performance evaluationrequired for dental equipment. A Certificate of Registration has now been issued. The facilitywas cited for being unregistered as well as the health related violations noted during the inspection.

File Closed.

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C-1450 - Uncredentialed Technologists - MedCure PA - Houston, Texas

On January 11, 2000, the Agency received an anonymous complaint alleging that the Registrantallowed uncredentialed technologists to perform radiographs. An Agency investigation determinedthree technologists performed radiographs at the facility. Two were credentialed. The thirdtechnologist, had a certificate that expired on December 31, 1999, but had performed radiographsduring January of 2000. The Registrant was cited for allowing an uncredentialed individual tooperate the x-ray equipment.

File Closed.

C-1451 -* Health and Safety Code-Chapter 241.051(d)

File Closed.

C-1452 - Unregistered Laser - Humphrey’s Salon/Malouf Dermatology - Irving/Ft. Worth, Texas

On January 13, 2000, the Agency received an anonymous complaint alleging that a facility wasoperating an unregistered laser. An Agency investigation determined the facility was not operatinga laser. However, it was determined that a physician associated with the facility took referrals forhair removal procedures involving the use of a laser at another location. An investigation at thesecond location found a laser that was not registered That facility was cited for the violation.

File Closed.

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C-1453 - Unregistered X-Ray Equipment - Island Medical Clinic - Port Aransas, Texas

On February 4, 2000, the Agency received an anonymous complaint alleging that an unregisteredfacility was advertising and performing x-ray services. An Agency investigation determined thatthe office was open and had an x-ray machine and operational processor. However, the x-raymachine was inoperative due to a malfunctioning timer. During the inspection no x-ray log norfilms were discovered that would indicate use of the x-ray machine. The inspector informed thefacility of requirements to register the equipment within 30 days of performing the firstradiographs. The complaint could not be substantiated.

File Closed.


File Closed.

C-1455 - Unauthorized Use of X-Ray Equipment - MacGregor Medical Association - Houston,Texas

On November 13, 1999, the Agency received an anonymous complaint alleging that an x-raymachine designated for medical diagnostic radiography was used to perform unauthorized x-rayson a dog belonging to an x-ray technologist employed by the facility. An Agency investigationconfirmed that a dog was x-rayed on August 7, 1999, in violation of the Registrant’s authorizeduse for the equipment. In addition, two x-ray technologists held the animal during the procedurewithout the use of protective apron, gloves, or other shielding. The Registrant was cited forunauthorized use of an x-ray machine, failure to use appropriate protective devices, and anuncredentialed equipment operator.

File Closed.

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C-1456 - Uncredentialed Technologist - South Texas Spinal Clinic - San Antonio, Texas

On February 16, 2000, the Agency received an anonymous complaint alleging that a Registrantallowed an uncredentialed technologist to perform radiographs. An Agency investigationdetermined the technologist is credentialed through the Texas State Board of Medical Examinersand is currently listed on the Non-Certified Technologist’s (NCT) registry. However, thetechnologist performed oblique lumbar radiographs, a dangerous and hazardous procedure forwhich the technologist was not credentialed. Further, the technologist performed radiographsduring January 1, 2000 through March 3, 2000 without a current NCT registry listing. TheRegistrant was cited for allowing a technologist to perform procedures without credentials and forallowing an NCT to perform dangerous or hazardous procedures.

File Closed.


File Closed.

C-1458 - Regulation Violations - McGregor Medical Association - Houston, Texas

On February 24, 2000, the Agency received an anonymous complaint alleging that processorquality control was not performed as required by regulation. An Agency investigation identifiedthe following violations. The Registrant: failed to perform the image quality evaluation with thephantom at the correct time intervals; failed to establish valid operating levels for processorperformance evaluation; and failed to cease performing mammography when the analysis ofquality control tests, for phantom images, indicated the density difference limits were exceeded.The Registrant was cited for the violations.

File Closed.

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File Closed.

C-1460 - Uncredentialed Technologist - Metro Imaging and Surgical Clinic - Dallas, Texas

On February 28, 2000, the Agency received an anonymous complaint alleging a Registrantallowed an uncredentialed technologist to perform radiographs. The Agency was unable tosubstantiate the allegation. The physician indicated that he operates the x-ray equipment and onoccasion his medical assistant positions patients.

File Closed.

C-1461 - Uncredentialed Technologists - Heights Diagnostic Imaging Center - Houston, Texas

On February 24, 2000, the Agency received an anonymous complaint alleging that anuncredentialed technologist was performing computed tomography (CT) and an underexperiencedmammography technologist was performing unsupervised mammograms. An Agency investigationdetermined that the CT technologist was credentialed and the mammography technologist did notperform unsupervised mammograms. The Registrant was cited for other violations found duringthe investigation.

File Closed.

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C-1462 - Regulation Violations - X-Ray Inspection, Inc. - Pearland, Texas

On March 6, 2000, the Agency received a complaint alleging that the Licensee allowedradiographers to: share individual personnel monitoring badges; that one badge may have beendeliberately “overexposed; that badges were not always returned to the processor in a timelyfashion; and badges were not exchanged in a timely fashion. An Agency investigation determinedbadges were individually assigned and returned to the processor in a timely fashion. Personnelmonitoring records indicated exposures were below regulatory limits.

File Closed.

C-1463 - Uncredentialed Technologist - Houston Medical Clinic - Houston, Texas

On March 8, 2000, the Agency received a complaint alleging that a an uncredentialed individualwas taking x-rays and an individual was practicing medicine without state licensure. An Agencyinvestigation determined that the massage therapist alleged to have performed x-ray procedureshad left the facility three months prior to this investigation. The individual alleged to have beenpracticing medicine was available and was assisting a licensed physician at the facility. TheRegistrant was cited for failing to notify the Agency within 30 days of change of radiation safetyofficer.

File Closed.

C-1464 - Unauthorized Site - X-Ray Inspection, Inc. - Pearland, Texas

On February 25, 2000, the Agency received a complaint alleging a Licensee was storingradioactive material and operating a radiography business at an unauthorized location and had noradiation safety officer on site. An Agency investigation substantiated the allegations. TheLicensee was cited for the violations.

File Closed.

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C-1465 - Regulation Violation - Diagnostic Clinic - San Antonio, Texas

On March 9, 2000, the Agency received a complaint alleging a mammography facility was notproviding mammograms for comparison upon request by another facility. An Agencyinvestigation determined the company had declared bankruptcy and gone out of business onFebruary 29, 2000. During the month of March 2000, the medical records were in transition.After March 31, 2000, a new procedure was put in place for obtaining films.

File Closed.

C-1466 - Unlicensed Source - Roxar Inc. - Houston, Texas

On February 7, 2000, the Agency received an anonymous complaint alleging an unlicensedcompany was processing and distributing radioactive material. An Agency investigation did notsubstantiate the allegations. The location was a sales office only and does not receive gauges atthe location. Gauges sold by the office are shipped directly from the manufacturer to thecustomers. A radiation survey of the facility did not detect any radiation above background.

File Closed.

C-1467 - Uncredentialed Technologists - Childress Family Clinic, PA - Childress, Texas

On March 31, 2000, the Texas Department of Radiological Technologist Certification Program(MRT) notified the Agency that they had received an anonymous complaint alleging that theChildress Family Clinic, PA, had persons not listed as MRT, Limited MRT, or Non-CertifiedTechnician (NCT) performing X-Ray procedures. An Agency investigation determined that forthe period April 21, 1999, through April 22, 2000, two technicians, currently working under anewly issued hardship exemption, had performed X-Ray procedures at the facility. The facilitiesprevious hardship exemption had expired April 20, 1999, and had not been renewed by the OfficeManager, who had been terminated for cause. The facility was issued a Notice of Violation thathad already been corrected by issuance of the newly issued hardship exemption.

File Closed.

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THIS PAGE IS INTENTIONALLY BLANK

19

INCIDENTS CLOSED SINCE FOURTH QUARTER 1999

NO INCIDENTS WERE CLOSED SINCE FOURTH QUARTER 1999

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21

COMPLAINTS CLOSED SINCE FOURTH QUARTER 1999

NO COMPLAINTS WERE CLOSED SINCE FOURTH QUARTER 1999

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APPENDIX A

SUMMARY OF HOSPITAL OVEREXPOSURESREPORTED DURING THE FIRST QUARTER 2000

NO HOSPITAL OVEREXPOSURES WERE REPORTED DURING FIRST QUARTER 2000

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APPENDIX B

SUMMARY OF RADIOGRAPHY OVEREXPOSURESREPORTED DURING FIRST QUARTER 2000

Houston, Texas

Radiographic Specialists Incorporated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Pasadena, Texas

Technical Welding Labs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

South Houston, Texas

GCT Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

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APPENDIX C

ENFORCEMENT ACTIONS FOR FIRST QUARTER 2000

Enforcement Conference: T.W. Bohannan, D.D.S. - Hurst, Texas - Dental

On January 14, 2000, an Enforcement Conference was held with T. W. Bohannan, D.D.S., P.C.Registrant representatives attending the conference were T. W. Bohannan, D.D.S., WandaBohannan, and Melissa Crow. Agency representatives attending the conference were Messrs.Quincy Wickson (Chair), Rick Munoz, and Thomas Caldwell and Madames Karan Rains andCathy McGuire.

The conference was held as a result of the type, severity level, and repetitive nature of violationsnoted during an Agency inspection conducted at the Registrant’s facility on August 17, 1999.

The participants were introduced and the procedure for conducting the conference was explained.

The violations cited in the Notice of Violation dated September 16, 1999, and the responses to theviolations, were reviewed by Ms. Karan Rains.

After reviewing the violations and responses, the Registrant’s representatives were excused whilea caucus was held by the Agency representatives. During the caucus, the following wasdetermined:

1. The Agency will increased the Registrant’s inspection frequency to every 2 ½ years insteadof the routine inspection frequency of every 5 years.

2. It was recommended that a service company perform routine compliance tests at anincreased frequency.

After the caucus, the Registrant’s representatives returned and were informed of the itemsdiscussed during the caucus. They agreed to these items and the conference was concluded.

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Enforcement Conference: Castle Dental Centers - Houston, Texas - Dental

On January 25, 2000, an Enforcement Conference was held with Castle Dental Centers.Registrant representatives attending the conference were Donna D. Gained, Radiation Coordinator,Dr. Mash Amer., Regional Dental Director, Todd Busch, Regional Operations Director -Houston, and Steve Days, Regional Operations Director - Austin. Agency representativesattending the conference were Messrs. Quincy Wickson (Chair), Rick Munoz, Thomas Caldwell,and Ken Moon and Madames Jackie Carter, June Ayers, Cathy McGuire, and Jody Miller.

The conference was held as a result of the type, number, severity level, and repetitive nature ofviolations noted during Agency inspections conducted at the Registrant’s facility and the failureof the Registrant to respond to the Notices of Violation in a timely manner.


The violations cited in the Notices of Violation, and the responses to the violations, were reviewedby Madames Jackie Carter and June Ayers.


1. The Registrant shall submit to the Agency an updated radiation manual containing a set ofoperating and safety procedures, for Agency review, within 30 days of receipt of thismemorandum.

2. The Registrant shall submit to the Agency a schedule indicating the due dates for routinecompliance tests for each site within 30 days of receipt of this memorandum.

3. The Registrant shall establish a procedure to ensure 30 day responses for Notices ofViolation, within 30 days of receipt of this memorandum.

4. The incomplete routine compliance tests will be redone to complete the missing data,within 30 days of receipt of this memorandum.

5. The Registrant must make the commitment that, if Ms. Donna D. Gained requiresassistance to perform the tasks of Radiation Coordinator, this assistance will be provided.


29

Enforcement Conference: Tenet Health Systems, dba: Brownsville Medical Center - Brownsville,Texas - Mammography

On January 27, 2000, an Enforcement Conference was held with Tenet Health Systems, dba:Brownsville Medical Center. Registrant representatives attending the conference were Mr. FrankJ. Bolanos, Director of Radiology, Ms. Ruth Esquivel, and William McKinney, M.D. Agencyrepresentatives attending the conference were Messrs. Rick Munoz (Chair), Quincy Wickson, andJerry Cogburn and Madames June Ayers and Cathy McGuire.

The conference was held as a result of the type, number, and severity level of violations notedduring an Agency inspection conducted at the Registrant’s facility and a significant, unacceptabledeficiency in the application and overall effectiveness of the radiation safety program.


The violations cited in the Notice of Violation, and the responses to the violations, were reviewedby Mr. Jerry Cogburn and Ms. June Ayers.


1. The Registrant shall submit, by February 7, 2000, an updated policy to establishprocedures for cleaning and disinfecting mammography equipment.

2. The Registrant shall re-read 171 mammograms performed by Purnia L. Backlas, M.D.,or submit, by February 7, 2000, documentation to verify the number of mammogramreadings performed by Dr. Backlas. If the facility is not able to obtain the documentationor have the mammograms re-read within the time frame allotted, mammography patientsmust notified. If the time frame is too restrictive, the Agency must be notified in order togrant additional time. The documentation was submitted at the conference, reviewed, andapproved by the Agency.

3. The Registrant shall submit, by February 7, 2000, an updated mammography medicaloutcomes audit program.

4. The Agency will increase the Registrant’s unannounced inspection frequency andadministrative penalties may be assessed pending the results of these inspections.


30

Enforcement Conference: Michael A. Mantas, M.D., P.A., dba: Associated Medical Providers-Dallas, Texas - Medical

On February 8, 2000, an Enforcement Conference was held with Michael A. Mantas, M.D.,P.A., dba: Associated Medical Providers. Associated Medical Providers representatives attendingthe conference were Michael A. Mantas, M.D. and Ms. Janice Robinson. Agency representativesattending the conference were Mr. Quincy Wickson (Chair) and Madames Debbie Borden, JackieCarter, Cathy McGuire, and Angie Thompson.

The conference was held as a result of Associated Medical Providers’ failure to adequately registerx-ray equipment and to adequately respond to several attempts to obtain voluntary compliance.


The violation regarding the failure of Associated Medical Providers to register x-ray equipment,and the response by Michael A. Mantas, M.D., P.A., were reviewed by Ms. Jackie Carter.

After reviewing the violations and responses, Associated Medical Providers’ representatives wereexcused while a caucus was held by the Agency representatives. During the caucus, the followingwas determined:

1. An Administrative Penalty in the amount of $1,000.00 will be assessed. The PreliminaryReport for Assessment of Administrative Penalties will be received under a separate action.

2. Since a new Certificate of Registration has been issued, inspections will be conducted inaccordance with the schedule for a new registrant.

3. The Registrant shall submit a written commitment to the Agency, within 30 days of receiptof this memorandum, that must include: a method for promptly handling correspondenceand telephone calls from the Agency; the name(s) of the individual(s) responsible forensuring that communication with the Agency is maintained and the individual(s) is\are tobe knowledgeable in x-ray and Agency regulations, including the required response times;if a new radiation safety officer (RSO) is assigned, their qualifications must be submittedwithin 30 days of receipt of this memorandum; and if the duties of the R.S.O. is delegatedto individuals at various subsites, these individuals must be aware of and trained in theresponsibilities of an RSO, as described in 25 TAC §289.226.

After the caucus, Associated Medical Providers’ representatives returned and were informed ofthe items discussed during the caucus. They agreed to these items and the conference wasconcluded.

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Enforcement Conference: Cogdell Memorial Hospital - Snyder, Texas - Medical

On February 15, 2000, an Enforcement Conference was held with Cogdell Memorial Hospital.Licensee representatives attending the conference were Messrs. Jeff Reecer, Administrator, andBrian Moffett, and Ms. Norma Adams. The representative attending the conference for Numed,Inc. was John Pickett. Agency representatives attending the conference were Messrs. Rick Munoz(Chair), Michael Dunn, David M. Wood, and Thomas Caldwell and Madames Karan Rains andCathy McGuire.

The conference was held as a result of the type, number, and severity level of violations notedduring Agency inspections conducted at the Licensee’s facility.


The violations cited in the Notices of Violation, and the responses to the violations, were reviewedby Mr. Michael Dunn and Ms. Karan Rains.

After reviewing the violations and responses, the Licensee’s and Numed, Inc.’s representativeswere excused while a caucus was held by the Agency representatives. During the caucus, thefollowing was determined:

1. The Licensee shall submit a corrected copy of a Medical Physicist's report within 30 daysof receipt of this memorandum.

2. If the Licensee cannot obtain the personnel monitoring records for Michelle Dingle, a doseassessment must be made and a copy of the assessment submitted to the Agency, within30 days of receipt of this memorandum.

3. The Licensee shall institute a written tracking procedure that must include nuclearpharmacy records, physician records, etc., to ensure that doses are not lost. A copy of thistracking procedure must be submitted to the Agency within 30 days of receipt of thismemorandum.

4. The Agency will increase the Licensee’s unannounced inspection frequency andadministrative penalties may be assessed pending the results of these inspections.

After the caucus, the Licensee’s and Numed, Inc.’s representatives returned and were informedof the items discussed during the caucus. They agreed to these items and the conference wasconcluded.

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Enforcement Conference: Harris Methodist Hospital - Ft. Worth, dba: Doris Kupferle BreastCenter - Ft. Worth, Texas - Mammography

On February 17, 2000, an Enforcement Conference was held with Harris Methodist Hospital - Ft.Worth, dba: Doris Kupferle Breast Center. Registrant representatives attending the conferencewere Messrs. Barclay Berdan, Jeff Layne, and John B. Tauser, and Madames Dede Dickinson,Jeanne T. Reardon, and Wanda Hall. Agency representatives attending the conference wereMessrs. Rick Muñoz (Chair), Tom Godard, Jerry Cogburn, and Thomas Caldwell and Messrs.Leanne Myers, Jo Turkette, and Cathy McGuire.

The conference was held as a result of the type, number, severity level, and repetitive nature ofviolations noted during an Agency inspection conducted at the Registrant’s facility on October 20,1999.


The violations cited in the Notice of Violation, and the responses to the violations, were reviewedby Mr. Jerry Cogburn.


1. The Agency will increase the Registrant’s unannounced inspection frequency andadministrative penalties may be assessed pending the results of these inspections.

2. The Registrant’s representatives expressed concern regarding credential requirements onmobile mammography units being assessable to possible duplication. An Agencyrepresentative will talk to the appropriate Board to see if optional recourse is available todeal with the possibility that credentials would be unsecured on the mobile mammographyunits. This Agency will advise the Registrant of options available.


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Enforcement Conference: Robert Silva, M.D., P.A., dba: San Antonio Neurology Offices - SanAntonio, Texas - Medical

On February 22, 2000, an Enforcement Conference was held with Roberto Silva, M.D., P.A.,dba: San Antonio Neurology Offices. The Registrant’s representative attending the conferencewas Roberto Silva, M.D. Agency representatives attending the conference were Messrs. QuincyWickson (Chair) and Rick Munoz and Madames June Ayers and Cathy McGuire.

The conference was held as a result of the type, number, severity level, and repetitive nature ofviolations noted during Agency inspections conducted at the Registrant’s facility.


The violations cited in the Notices of Violation, and the responses to the violations, were reviewedby Ms. June Ayers.

After reviewing the violations and responses, the Registrant’s representative was excused whilea caucus was held by the Agency representatives. During the caucus, the following wasdetermined:

1. The Registrant shall submit to the Agency a written response to each violation within 45days of receipt of this memorandum. This response must include: a copy of the techniquechart; a copy of the operating and safety procedures; and a copy of the maintenanceschedule.

2. The Registrant shall submit to the Agency a written commitment that the duties andresponsibilities of the radiation safety officer (RSO) will be reviewed with the current RSOwithin 45 days of receipt of this memorandum. If a new RSO is assigned, the individual’squalifications must be submitted to the Agency.

3. The Registrant shall submit to the Agency a copy of the medical physicist's completedreport within 45 days of receipt of this memorandum.

4. An unannounced reinspection will occur after completion of these corrective actions.Failure to comply or if the reinspection determines that the corrective actions were notadequately performed, a $12,000.00 penalty will be assessed by the Agency.

After the caucus, the Registrant’s representative returned and was informed of the items discussedduring the caucus. He agreed to these items and the conference was concluded.

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Enforcement Conference: Berry Fabricators - Corpus Christi, Texas - Industrial Radiography

On February 29, 2000, an Enforcement Conference was held with Berry Fabricators. Licenseerepresentatives attending the conference were Messrs. Charles Good and James Coulter. AgencyRepresentatives attending the conference were Messrs. Rick Muñoz (Chair), David Fogle, and BobGreen and Ms. Cathy McGuire.

The conference was held as a result of the type, number, and severity level of violations notedduring an Agency inspection conducted at the Licensee’s facility on December 2, 1999, and asignificant, unacceptable deficiency with regard to the application and overall effectiveness of theirradiation safety program.


The violations cited in the Notice of Violation, and the responses to the violations, were reviewedby Mr. Bob Green.

After reviewing the violation and response, the Licensee’s representatives were excused while acaucus was held by the Agency representatives. During the caucus the following was determined:

1. The Licensee shall furnish, by April 10, 2000, a copy of their inspection and maintenanceform, information form, and content/implementation audit form for their RadiationProtection Program.

2. The Agency will increase the Licensee’s unannounced inspection frequency andadministrative penalties may be assessed pending the results of these inspections.

After the caucus, the Licensee’s representatives returned and were informed of the items discussedduring the caucus. They agreed to these items and the conference was concluded.

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Enforcement Conference: Cyvon Imaging, Inc., dba: Community Diagnostics - Dallas, Texas -Mammography

On March 7, 2000, an Enforcement Conference was held with Cyvon Imaging, Inc. dba:Community Diagnostics. Registrant representatives attending the conference were Mr. BobMcHenry and Ms. Yvonne McHenry. Agency Representatives attending the conference wereMessrs. Rick Muñoz (Chair), Jerry Cogburn, and Thomas Caldwell and Ms. Cathy McGuire.

The conference was held as a result of the type, number, and severity level of violations notedduring an Agency inspection conducted at the Registrant’s facility on December 3, 1999, and asignificant, unacceptable deficiency in the application and overall effectiveness of their radiationsafety program.



After reviewing the violation and response, the Registrant’s representatives were excused whilea caucus was held by the Agency representatives. During the caucus, the following wasdetermined:

1. The Registrant failed to cease utilizing the darkroom immediately after the darkroom fogtest indicated the fog density limit had been exceeded. The registrant shall provide theAgency a copy of the darkroom fog tests results, by April 1, 2000.

2. The Registrant failed to document a quality assurance program specific to Mammographicimaging. Policy and procedures must be provided to the Agency by April 1, 2000 andmust include: densitometer and sensitometer corrections to their manual; an audit forpathology; a processor maintenance log; a procedure for quarterly review by Dr. Nelson;and a policy to discontinue the use of the Rodium filter.

3. The Agency will require the lead interpreting physician to review the mammographyquality control documents on a monthly basis, beginning on April 1, 2000, and continuingfor one year. Documentation must be provided to the Agency to verify compliance.

4. The Agency will increase the Registrant’s inspection frequency and administrative penaltiesmay be assessed pending the results of these inspections.

After the caucus, the Registrant’s representatives were informed of the items discussed during thecaucus. They agreed to these items and the conference was concluded.

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Enforcement Conference: Showtech Production, Inc. - Grand Prairie, Texas - Laser

On March 8, 2000, an Enforcement Conference was held with Showtech Production, Inc. TheRegistrant’s representative attending the conference was Mr. Keith Kettrey. Agencyrepresentatives attending the conference were Messrs. Rick Muñoz (Chair), and Thomas Caldwelland Madames Karan Rains, Latisha Merritt, Irma Gonzales, and Cathy McGuire.

The conference was held as a result of an Agency inspection conducted at the Registrant’s facilityon December 3, 1999, that determined the Registrant performed a laser light show without acertificate of registration.


The violations cited in the Notice of Violation, and the responses to the violations, were reviewedby Ms. Karan Rains.

After reviewing the violation and response, the Registrant’s representative was excused while acaucus was held by the Agency representatives. During the caucus the following was determined:

1. A Cease and Desist Order was rescinded.

2. The Registrant shall submit written notification to the Agency, at least 7 days prior to anylaser light show performance, and receive written approval from the Agency prior to anylaser light show performance.

3. The Registrant performed two laser lights shows even though the facility was notregistered. Administrative penalties in the amount of $5,000 were assessed. The firstviolation occurred during the time period when the Registrant was not registered and apenalty of $2,000 was assessed. The second violation occurred while the Registrant wasunregistered and under a Cease and Desist Order to not perform laser light shows. Apenalty of $3,000 was assessed for this occurrence.


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Enforcement Conference: Doctor’s Hospital Tidwell - Tidwell, Texas - Mammography

On March 14, 2000, an Enforcement Conference was held with Doctors Hospital Tidwell.Registrant representatives attending the conference were Mr. Carlos Muñoz and Ms. PushpaThomas. Agency Representatives attending the conference were Messrs. Rick Muñoz (Chair) andJerry Cogburn and Ms. Cathy McGuire.

The conference was held as a result of the type, number, and severity level of violations notedduring an Agency inspection conducted at the Registrant’s facility on January 27, 2000,and asignificant, unacceptable deficiency in the application and overall effectiveness of their radiationsafety program.



After reviewing the violation and response, the Registrant’s representatives were excused whilea caucus was held by the Agency representatives. During the caucus the following wasdetermined:

1. The Registrant shall notify all patients who received procedures during the period of April13, 1999, through January 27, 2000. The notification letter must be approved by theAgency prior to posting.

2. The lead interpreting physician shall conduct and document a monthly review of themammography quality control program for a period of one year. The physician’s reviewmust be available for review by Agency inspectors.

3. The Registrant shall provide the Agency with a strategy of implementation for a check andbalance system to ensure overview of the mammography quality control program.


5. It was determined the Registrant may remove the Notice of Failure currently posted at theirfacility. An Agency letter was provided to the Registrant indicating that the responseprovided during the enforcement conference was adequate and brought the facility intocompliance.


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Enforcement Conference: Image Imprinter’s, Inc., dba: Plano Diagnostic Imaging Center - Plano,Texas - Mammography

On March 21, 2000, an Enforcement Conference was held with Image Imprinters, Inc, which wasbought by Healthsouth. The Registrant’s representative attending the conference was Ms. CynthiaRailsback. Agency Representatives attending the conference were Messrs. Rick Muñoz (Chair),Thomas Caldwell, and Jerry Cogburn and Ms. Cathy McGuire.

The conference was held as a result of the type, number, and severity level of violations notedduring an Agency inspection conducted at the Registrant’s facility on January 20, 2000,and asignificant, unacceptable deficiency in the application and overall effectiveness of their radiationsafety program.




1. A Notice of Violation will be issued to Healthsouth, because they bought Image Imprinters,citing the Registrant for failure to provide notification to the Agency within 30 days of achange of radiation safety officer, interpreting physician, and address.

2. The Registrant shall provide written notification of change of ownership of ImageImprinters, Inc. to Healthsouth.

3. A Cease and Desist Order will be issued to the Registrant unless the Agency receivesnotification of the change of interpreting physician and documentation of requiredcredentials by March 30, 2000.

4. The Registrant shall implement and provide documentation of a Quality AssuranceProgram Committee review on a monthly basis to begin April 1, 2000, and continue forone year. The Committee will be comprised of the interpreting physician, Ms. Railsback,and the mammography technician.



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Enforcement Conference: Doctor’s Hospital 1997 L.P. - Houston, Texas - Medical

On March 30, 2000, an Enforcement Conference was held with Doctor’s Hospital 1997 LP, dba:Doctor’s Hospital Parkway. The Registrant’s representative attending the conference was ChuckNeas, Director of Radiology. Agency representatives attending the conference were Messrs.Quincy M. Wickson (Chair), Rick Munoz, and Thomas Caldwell and Madames Jackie Carter andCathy McGuire.

The conference was held as a result of the type, number, and severity level of violations notedduring Agency inspections conducted at the Registrant’s facility.


The violations stated in the Notices of Violation, and the responses to the violations, werereviewed by Ms. Jackie Carter.


1. The Registrant shall submit a written commitment to the Agency, within 30 days of receiptof this memorandum, detailing the steps taken to ensure that corrective actions will betaken within 30 days of receipt of any adverse findings on a Medical Physicist's report orany violation cited in a Notice of Violation.

2. The Registrant shall submit a copy of the training criteria for technologists within 30 daysof receipt of this memorandum.

3. The Registrant shall submit a written commitment to the Agency, within 30 days of receiptof this memorandum, that the x-ray machine in Room 1 will be monitored on a monthlybasis due to the recurring problems encountered with this machine.

4. The Registrant shall submit a written commitment within 30 days of receipt of thismemorandum that the radiation safety officer will review all documentation related toradiation safety and sign off on these documents.

5. The Registrant shall submit a copy of the darkroom light leak test result within 30 days ofreceipt of this memorandum.

6. The Agency will increase the Registrant’s unannounced inspection frequency andadministrative penalties may be assessed pending the results of these inspections

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REDACTED - 8/2003 First Quarter 2000 Summary of ...1 SUMMARY OF INCIDENTS FOR FIRST QUARTER 2000...

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